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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Bacterial Reverse Mutation Test:

AMES (1985): The test results indicated that the compound is not mutagenic under the test system used.

AMES (1987): The test results showed that the test substance is not mutagenic under the test system used.

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
9 October 1985 - 18 Octobre 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: Principles and methods for their detections, modification mutagenic activity "Chemical Mutagens" T. Sugimura and M. Nagao, Vo1.6 pp.41-61 (1980) Plenum Press, (New York)
Deviations:
not specified
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Test material information:
Composition 1
Target gene:
Histidin
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
0, 10, 25, 50, 70, 100, 250 and 500 micrograms
Positive controls:
yes
Positive control substance:
2-nitrofluorene
sodium azide
N-ethyl-N-nitro-N-nitrosoguanidine
other: 2-Aminoanthracene; 9-Aminoacridine hydrochloride
Details on test system and conditions:
After mixing the test m aterial, phosphate buffer or S-9 mix, culture of tester strain, the mixture was incubated under shaking at 37°C in a test tube for 20 minutes, top agar was added to the mixture and then the mixture was poured on minimal agar plate. The plates were incubated at 37°C for 2 days and scored for revertants.
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Positive controls valid:
not specified
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Positive controls valid:
not specified
Key result
Species / strain:
E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Positive controls valid:
not specified
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Positive controls valid:
not specified
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Positive controls valid:
not specified
Additional information on results:
See attachment for result tables.
Conclusions:
The mutagenic activity of the test item was tested by the in vitro direct and metabolic acitivation assays using Salmonella typhimurium TA100, TA1535, TA1537, TA98 and
Escherichia coli WP-2. The test results indicated that the compound is not mutagenic under the test system used.
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
January 5 - January 17, 1987
Reference:
Composition 0
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
Test material information:
Composition 1
Target gene:
Histidine
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Test concentrations with justification for top dose:
16, 31,63, 125, 250 and 500 µg/plate
Solvent controls:
yes
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
N-ethyl-N-nitro-N-nitrosoguanidine
Details on test system and conditions:
Cultures of each strain were prepared by incubating an aliquot of strain at 37°C for 8 hours.
Pre-incubation method:
After mixing the test material solution, the phosphate buffer (pH 7.4) or the S9 mix and the culture of the test strain in a test tube, the mixture was incubated at 37°C for 20 minutes. Then top agar was added in the test tube, the mixture of each tube was poured on minimal agar plate. The plates were incubated at 37°C for 2 days and scored for revertants.
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Key result
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Additional information on results:
See attachment for the results.
Conclusions:
The mutagenic activity of the test substance was tested by the in vitro direct and metabolic activation assays using Salmonella typhimurium TA 100, TA 1535, TA 98, TA 1537 and Esherichia coli WP2uvrA.
The test results showed that the test item is not mutagenic under the test system used.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification